Last week, the European Parliament voted on a draft for the Tobacco Products Directive (TPD) and declined to accept the European Commission&#39 s proposal to regulate electronic cigarettes (“e cigarettes”) as medicines. The majority of Members of European Parliament (“MEPs”) supported using a mixture of tobacco regulation (e.g., controls on promotion) and medicines style regulation (e.g., reporting of adverse reactions) for all nicotine products (including medicines), and applying medicines regulation to products that make medicinal claims.

However, just prior to the Parliament&#39 s decision the United Kingdom (“UK”) Medicines and Healthcare Products Regulatory Agency (“MHRA”) had announced that the UK government would regulate e cigarettes and other nicotine containing products (“NCPs”) as medicines. After the vote the MHRA stated that it still believed that medicinal regulation of NCPs is in the best interests of the public health, and they will continue to encourage companies voluntarily to seek a medicinal license for their NCPs. Comparable nicotine replacement products (e.g. gums, patches, inhalator), for example, are licensed as medicines.

Earlier the Commission on Human Medicines (“CHM”) working group on NCPs had concluded that the NCPs currently on the market do not meet appropriate standards of safety, quality, and efficacy. Their study found that nicotine levels can vary considerably from the labeled content, and the amount of nicotine per product can differ from batch to batch. Regarding e cigarettes, which deliver nicotine via a cartridge, there is also no data concerning the manufacture of the cartridge or device to suggest consistent nicotine doses across multiple cartridges or multiple devices. Additionally, the cartridges may contain potentially toxic elements at unexpectedly high doses, which could produce adverse effects, particularly in vulnerable patient groups.

The CHM Report accepted that there is consistent evidence from a variety of sources that most e cigarette use may be used by individuals seeking to either quit or reduce their amount of smoking regular cigarettes, with the hope that e cigarettes are less harmful because they are not burned/smoked. Currently, however, there is a paucity of long term health effects of e cigarettes, particularly in terms of comparative data to comparable burned/smoked counterparts, so it is unclear whether e cigarettes would be safer than traditional burned/smoked cigarettes.

FDA has stated that it intends to issue regulations on e cigarettes shortly but has not provided any definitive timetable when this will occur. In September, 40 U.S. state Attorneys General urged FDA to assume regulatory oversight over e cigarettes. They expressed deep concern that the use of e cigarettes was becoming increasingly widespread, particularly since nicotine is a highly addictive drug. In addition, they wanted FDA to impose advertising restrictions and other measures to help curb the marketing and sale of e cigarettes to young people.

In Europe, tobacco industry representatives and health campaigners heavily lobbied the MEPs, arguing that e cigarettes undermine the years of anti smoking campaigns that have shown some progress, where young people are now being “tricked into taking up smoking” via the e cigarette route. In response, the Electronic Industry Trade Association (“ECITA”) responded via spokesperson Katherine Devlin to the allegations, saying, “There is no evidence that e cigarettes are a gateway if anything, it is the other way around”. And Charles Hamshaw Thomas, Corporate Affairs Director of Britain&#39 s largest e cigarette brand by sales volume, E Lites, said, “This is a fantastic result for public health and the millions of smokers around Europe who are switching to e cigarettes. . . . Common sense has prevailed.”

It would seem that there must be some underlying concern that if e cigarettes were to prove to be safer than inhaling tobacco smoke, such information may lead to more people using e cigarettes beyond the possibility for traditional cigarette smokers just switching to e cigarettes. Whether e cigarette use will ultimately lead to smoking traditional cigarettes is unclear but could also be an effect. Without some regulatory health control rather than just limiting e cigarettes to tobacco smokers wishing to stop smoking, there may result in a new take up of “vaping” (as it is known) that could result in far more people becoming addicted to nicotine than currently.